Implantable support with dilator attached to arm

ABSTRACT

A pelvic organ prolapse treatment device includes an implantable support configured to treat a prolapsed area of a patient such as urethrocele prolapse, cystocele prolapse, vault prolapse, uterine prolapse, enterocele prolapse, or rectocele prolapse. The support includes a body portion and an arm connected to the body portion, a knot connecting a suture to an end portion of the arm, and a tubular dilator disposed over and permanently connected to the knot. The tubular dilator has an aspect ratio of greater than 7.

BACKGROUND

Supports that are implanted to treat pelvic organ prolapse are generallysecured to an anatomical structure within the pelvis. Typically thesupport is placed inside the pelvis by attaching a suture line to atissue landmark, attaching the support to the suture line, and pullingon the suture line until the support is located at the landmark. Accessto the pelvis is sometimes gained through an incision formed in thevagina. Placement and retrieval of the suture line through the tissuelandmark can present challenges.

FIG. 1A is a schematic side view of a prior art suture line 10 attachedto a support 12 by a joint 14. Suitable exemplary supports 12 includesuture (shown) or support fabrics or arms attached to other implantabledevices. Examples of the joint 14 includes a knot (shown) formed in thesuture line 10 or other chemical or mechanical joints that attach theretrieval suture 10 to the support 12. The suture line 10 is directedthrough a tissue landmark 16 (for example a ligament) until the support12 is placed in the location desired by the surgeon, after which thejoint 14 and any excess portion of the support is trimmed off.

FIG. 1B is a schematic side view of the joint 14 pulled over the tissuelandmark 16. Some joints 14 can undesirably drag, snag, or catch on thetissue landmark 16 and resist movement of the suture line 10 through thetissue landmark 16.

FIG. 1C is a schematic side view of the joint 14 undesirably hung up onand impeding movement of the support 12 into the tissue landmark 16. Insome cases, the joint 14 tears the tissue landmark as the surgeon pullson the suture line 10, which necessitates the placement of anothersuture line and support. In some cases, the surgeon prefers to place thesuture line 10 at a different location and a snagged joint 14 willundesirably impede the surgeon's attempt to remove and relocate thesuture line 10.

Surgeons and surgical staff would welcome improvements made to theplacement of pelvic organ prolapse supports.

SUMMARY

One aspect provides a pelvic organ prolapse treatment device. The deviceincludes an implantable support configured to treat a prolapsed area ofa patient such as urethrocele prolapse, cystocele prolapse, vaultprolapse, uterine prolapse, enterocele prolapse, or rectocele prolapse.The support includes a body portion and an arm connected to the bodyportion, a knot connecting a suture to an end portion of the arm, and atubular dilator disposed over and permanently connected to the knot. Thetubular dilator has an aspect ratio of greater than 7.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated in and constitute apart of this specification.

The drawings illustrate embodiments and together with the descriptionserve to explain principles of embodiments. Other embodiments and manyof the intended advantages of embodiments will be readily appreciated asthey become better understood by reference to the following detaileddescription. The elements of the drawings are not necessarily to scalerelative to each other. Like reference numerals designate correspondingsimilar parts.

FIGS. 1A-1C illustrate a prior art suture line of an implant insertedinto a ligament.

FIG. 2 is a top view of one embodiment of a pelvic organ prolapsetreatment device.

FIG. 3A is a top view of one embodiment of an assembly including adilator insertable over a suture connected to an arm of the deviceillustrated in FIG. 2.

FIG. 3B is a top view and FIG. 3C is a perspective view of a knotemployed to secure the suture to the arm of the device as illustrated inFIG. 3A.

FIG. 4A is a perspective view, FIG. 4B is a side view, and FIG. 4C is across-sectional view of one embodiment of a dilator of the deviceillustrated in FIG. 2.

FIG. 5 is a side view of a swelled/expanded dilator being assembled toan arm of the device illustrated in FIG. 2.

FIG. 6 is a side view of a dilator connected to a knot and a portion ofan arm of the device illustrated in FIG. 2.

FIGS. 7A-7E are views of embodiments of an implantable supportintroduced through and engaged with tissue.

DETAILED DESCRIPTION

In the following Detailed Description, reference is made to theaccompanying drawings, which form a part hereof, and in which is shownby way of illustration specific embodiments in which the invention maybe practiced. In this regard, directional terminology, such as “top,”“bottom,” “front,” “back,” “leading,” “trailing,” etc., is used withreference to the orientation of the Figure(s) being described. Becausecomponents of embodiments can be positioned in a number of differentorientations, the directional terminology is used for purposes ofillustration and is in no way limiting. It is to be understood thatother embodiments may be utilized and structural or logical changes maybe made without departing from the scope of the present invention. Thefollowing detailed description, therefore, is not to be taken in alimiting sense, and the scope of the present invention is defined by theappended claims.

It is to be understood that the features of the various exemplaryembodiments described herein may be combined with each other, unlessspecifically noted otherwise.

Tissue includes soft tissue, which includes dermal tissue, sub-dermaltissue, ligaments, tendons, or membranes. As employed in thisspecification, the term “tissue” does not include bone.

Embodiments provide an implant having a knot connecting a suture to anend portion of an arm, and a tubular dilator disposed over andpermanently connected to the knot.

The phrase “permanently connected” means that the dilator does notseparate from the knot/arm juncture without tearing the arm or otherwisedamaging the implant. Removal of the dilator is achieved by cutting thearm of the implant and removing the severed portion of the arm and thedilator that is attached to the severed portion of the arm.

Embodiments provide an implant having a tubular dilator provided with anaspect ratio of greater than 7. The aspect ratio of the dilator isconfigured to allow the suture/arm juncture to be smoothly pulledthrough tissue when implanting the implant.

“Tubular dilator” means that a lateral cross-section of the dilator iscircular. The dilator is provided with an annular wall surrounding anopen channel (i.e., a tube), and a lateral cross-section of the tube ofthe dilator is circular.

“Aspect ratio” is defined to be the length of the dilator divided by theoutside diameter of the dilator, represented as L/D. As an example, anaspect ratio of greater than 7 requires that the length of the dilatoris at least a factor of 7 greater than the outside diameter of thedilator.

Embodiments provide an implantable support configured to treaturethrocele prolapse (the prolapse of the urethra into the vagina), acystocele prolapse (the prolapse of the bladder into the vagina), avault prolapse (the prolapse of the apex of the vagina, often after ahysterectomy), a uterine prolapse (the prolapse of the uterus into thevagina), an enterocele prolapse (the prolapse of the small bowel intothe vagina), or a rectocele prolapse (the prolapse of the largeintestine into the vagina). The implantable support includes an arm anda dilator that is placed over a portion of the arm, where the dilatorfacilitates movement of the arm through a tissue landmark.

FIG. 2 is a top view of one embodiment of an implantable support 50. Theimplantable support 50 includes a body portion 52, arms 54, 56, a suture58 connected with the arm 54, and a dilator 60 disposed over a portionof the arm 54 and a portion of the suture 58.

The body portion 52 includes an edge 60 that extends between a firstlateral side 62 and a second lateral side 64. In one embodiment, theimplantable support 50 is formed to have a bilateral symmetry such thatthe first arm 54 is similar to the second arm 56. The body portion 52 isprovided to support a prolapsed organ. In one embodiment, the bodyportion 52 is provided as a knitted polypropylene mesh, a wovenpolypropylene mesh, a knitted fabric, a woven fabric, a porous supportformed of human tissue such as an allograft of pericardium, or a poroussupport formed of non-human or xenograft tissue. One suitable example ofthe implantable support 50 includes the body portion 52 fabricated of aknitted polypropylene mesh available from Coloplast Corp., MinneapolisMinn.

The arm 54 has a first end 70 connected to both the edge 60 and thefirst lateral side 62 of the body portion 52. In one embodiment, the arm54 is attached by sewing, welding, or other means to the body portion52. In one embodiment, the arm 54 is integrally woven or knitted as amonolithic piece of the body portion 52.

The suture 58 is attached to a second end 72 of the arm 54, for examplewith a knot as described below.

In one embodiment, the implantable support 50 is shaped and configuredto treat a cystocele prolapse, or a prolapse on an anterior side of thevagina, and includes a tab 74 separate from the arm 54 that is connectedto the body portion 52 opposite of the edge 60.

When implanted, each arm 54, 56 is desirably attached to a tissuelandmark within the patient, for example a ligament, at a location thatallows the body portion 52 to support the prolapsed organ. The dilator60 is configured to be flexible to allow the dilator 60 to bend and flexas the arm 54 is drawn into and through the ligament. In addition, thedilator 60 is provided with a tapered profile that allows the arm 54 tobe drawn through the tissue landmark with a reduced level of resistance.

FIG. 3A and FIG. 3B are top views of the suture 58 connected to the arm54 of the support 50. In one embodiment, the suture 58 is attached tothe second end 72 of the arm 54 by a knot 80. With reference to FIG. 3B,the second end 72 of the arm 54 is folded to include a first fold 82 anda second fold 84 that combine to reduce the lateral dimension of thesecond end 72 of the arm 54. The knot 80 is secured around the foldedportions of the second end 72 of the arm 54 to capture both the arm 54and the suture 58. In one embodiment, the knot 80 is located at ajuncture of the arm 54 and the suture 58 (located where arrow 80 ispointing). In one embodiment, an excess portion 86 of the arm 54 istrimmed prior to attachment of the dilator 60.

FIG. 3C illustrates a perspective view of the knot 80. In oneembodiment, the knot 80 is provided as a nail knot including opposingfirst and second ends 90, 92 that extend away from a winding 94 of theknot 80. With reference to FIGS. 3A and 3B, the suture 58 is insertedinto the winding 94 prior to tightening of the knot 80 around the suture58 and the second end 72 of the arm 54. In this manner, suture 58 ispermanently attached to the arm 54. Alternatively, the knot 80 is formedby a portion of the suture 58 affixed to the second end 72 of the arm54.

FIG. 4A is a perspective view, FIG. 4B is a side view, and FIG. 4C is across-sectional view of one embodiment of a tubular, tapered dilator 60.The dilator 60 includes a central portion 100, a distal end 102, and aproximal end 104. The central portion 100 extends between a distalportion 106 and a proximal portion 108.

In one embodiment, the dilator 60 is a tubular dilator having an opening110 sized to receive the suture 58 (FIG. 2), where the opening 110extends to a recess 112 formed in the distal portion 106. The recess 112is sized and configured to be secured over the knot 80 (FIG. 3C).

The dilator 60 generally tapers in a converging orientation from thedistal portion 106 to the proximal portion 108. In one embodiment, thedilator 60 generally includes a tapered portion that has an angle A oftaper in the range between 1-5 degrees. One suitable taper for thedilator has an angle A of taper of approximately 1.3 degrees.

In one embodiment, the dilator 60 has an overall length L extendingbetween the distal end 102 and the proximal end 104 in the range between1-2 inches, and preferably in the range between 1.25-1.75 inches. Onesuitable overall length L for the dilator 60 is approximately 1.38inches.

In one embodiment, the dilator is provided with a diameter D measured atthe distal portion 106 in the range between 0.080-0.125 inches, andpreferably in the range between 0.090-0.1 inches. One suitable diameterD for the dilator 60 is approximately 0.094 inches.

The dilator 60 is configured to have an aspect ratio (i.e., L/D) in arange from 7-20. The dilator 60 is configured to have an aspect ratio ofgreater than 7, preferably the dilator 60 has an aspect ratio that isgreater than 10, and more preferably the dilator 60 has an aspect ratiothat is greater than 14. One suitable aspect ratio the dilator 60 isapproximately 15 for an overall length L of 1.38 inches and a diameter Dof 0.094 inches.

In one embodiment, the dilator 60 is fabricated from a plastic materialthat has a flexibility that is sufficient to allow the proximal end 104to be bent through at least 180 degrees and into contact with the distalend 102. An example of one suitable plastic material is asolvent-swellable polyurethane having a durometer of betweenapproximately 50-85 Shore D that provides the dilator 60 with aflexibility that is characterized by allowing the dilator 60 to be bentback upon itself. The dilator 60, when provided with this level offlexibility, is flexible or bendable enough to be formed into a circulararc associated with a circle having a radius between about 0.5-3 mm. Adilator with the flexibility to allow the dilator to bend through acircular arc associated with a radius of about 1 mm is suitably flexibleto allow the dilator 60 to bend as it passes through a ligament.

In one embodiment, the dilator 60 is fabricated from a solvent-swellablepolymer. One example of the dilator 60 is formed of a polymer thatswells in the presence of toluene such that when the toluene evaporatesthe remaining shrunken polymer is permanently attached over the knot 80and to the arm 54. In one embodiment, the dilator 60 is fabricated froma solvent-swellable polyurethane having a durometer of betweenapproximately 50-85 Shore D.

One acceptable process for forming the dilator 60 includes dipping amandrel of a desired shape repeatedly into a dispersion of polyurethaneparticles in a solvent carrier, and drying the dipped dilator betweendips to remove solvent and leave a layer of polyurethane on the mandrel.The dilator 60, after multiple dipping and drying cycles, is thus formedover the mandrel. Thereafter, the formed polyurethane dilator 60 isintroduced to a solvent, such as toluene, which swells the dilator 60and allows it to be removed from the mandrel. The swelled polyurethanedilator 60 is placed over the knot 80 and the suture 58 and the solventis evaporated off, resulting in the dilator 60 shrinking and becomingpermanently attached to the knot 80.

FIG. 5 is a side view of a swelled dilator 60 being assembled to the arm54 of the implant 50. In one embodiment, the dilator 60 is fabricatedfrom polyurethane that is selected to swell in the presence of toluene.The dilator 60 swells when soaked in toluene to provide a largerdimension of the recess 112 that is sized to encompass the knot 80. Inone embodiment, the recess 112 thus acquires a dimension that allows thedistal portion 106 of the dilator 60 to be placed over the knot 80 and aportion of the arm 54 and a portion of the suture 58. As describedabove, the second end 72 of the arm 54 is folded to include the folds82, 84 that constrict the arm 54 at the location where the knot 80 isplaced. The toluene-swelled dilator 60 is placed over the knot 80 andover the second end 72 of the arm. Evaporation of the solvent shrinksthe dilator 60 to permanently attach the dilator 60 to the arm 54 andthe knot 80.

FIG. 6 is a side view of the dilator 60 permanently attached over theknot 80. In one embodiment, the distal portion 106 is secured over theknot 80 and a portion of the arm 54 and a portion of the suture 58. Forexample, the distal portion 106 is secured over the knot 80 and about adistance of 0.125 inches over a portion of the arm 54. The dilator 60allows the arm 54 to follow the path of a needle with reduced resistancewhen placing the arm 54 into a tissue landmark.

In one embodiment, the recess 112 is swelled/expanded to a size that isjust large enough to accommodate the knot 80, and evaporation of thesolvent out of the dilator 60 shrinks the dilator 60 into a permanentattachment with the knot 80 only.

FIGS. 7A-7E are side views of one embodiment of the implantable support50 introduced through tissue T.

FIG. 7A is a schematic side view of the suture 58 pulling the arm 54 ofthe implantable support through a tissue landmark T. Examples of tissuelandmarks T include muscles, tendons, and ligaments. The surgeonaccesses the tissue landmark T through an incision, which is usually avaginal incision that provides access to the sacrospinous ligamentduring a procedure to treat pelvic organ prolapse.

In one embodiment, the surgeon will first pass a needle through thetissue landmark T to form an opening 120. In one useful approach, thesurgeon forms the opening 122 extending from a posterior side 122 to ananterior side 124 of the tissue landmark T, where the anterior side 124is located nearest to the vaginal incision that provides the surgeonwith access to the pelvic region. The suture 58 extends through theopening 120 and is employed to pull the arm 54 over a top portion of thetissue landmark T and through the opening 120.

FIG. 7B is a schematic side view of the dilator 60 entering the opening120 and moving from the posterior side 122 toward the anterior side 124of the tissue landmark T. The dilator 60 is permanently secured to oneor both of the arm 54 and/or the knot 80 and is suitably flexible toallow the proximal end 104 to bend as the dilator 60 and the arm 54 arepulled through the opening 120

FIG. 7C is a schematic side view of the proximal end 104 of the dilator60 passed through the tissue landmark T from the posterior side 122 tothe anterior side 124. The dilator 60 has a suitably low coefficient offriction relative to the tissue to allow the dilator 60 to slide throughthe tissue landmark T. The tapered dilator 60 provides for a gradualtransfer of the knot 80 through the opening 120 and through the tissuelandmark T.

FIG. 7D is a schematic side view of the dilator 60 employed to smoothlytransition the knot 80 from the posterior side 122 to the anterior side124 of the tissue landmark T. In contrast to the devices that have anexposed knot or an exposed abrupt end of an implant, the dilator 60allows the knot 80 that is attached to the suture 58 and the arm 54 tomove smoothly through the tissue landmark T.

FIG. 7E is a schematic side view of the dilator 60 and a portion of thearm 54 after passage through the tissue T. The arm 54 is thus placed inthe tissue T to anchor the body portion 52 of the implant 50 (FIG. 2) ina location selected to support and correct a prolapse of an organ. Aftersuch placement of the anchoring arm 54, the surgeon will trim off theexcess portion of the arm 54 projecting past the anterior side 124 ofthe tissue T to remove the excess material of the arm 54 and the dilator60.

Although specific embodiments have been illustrated and describedherein, it will be appreciated by those of ordinary skill in the artthat a variety of alternate and/or equivalent implementations may besubstituted for the specific embodiments shown and described withoutdeparting from the scope of the present invention. This application isintended to cover any adaptations or variations of medical devices asdiscussed herein. Therefore, it is intended that this invention belimited only by the claims and the equivalents thereof.

1-14. (canceled)
 15. A pelvic organ prolapse treatment devicecomprising: an implantable support configured to treat a prolapsed areaof a patient selected from the group consisting of urethrocele prolapse,cystocele prolapse, vault prolapse, uterine prolapse, enteroceleprolapse, and rectocele prolapse, the implantable support comprising: abody portion and an arm connected to the body portion; a knot connectinga suture to an end portion of the arm; and a tubular dilator disposedover and permanently connected to the knot; wherein the tubular dilatorhas an aspect ratio of greater than
 7. 16. The device of claim 15,wherein the tubular dilator surrounds a circumference of the knot. 17.The device of claim 15, wherein the tubular dilator is permanentlyconnected to the arm.
 18. The device of claim 15, wherein the tubulardilator has a length and more than 90% of the length is disposed overthe suture.
 19. The device of claim 15, wherein the aspect ratio of thetubular dilator is provided in a range from 7-20.
 20. The device ofclaim 19, wherein the aspect ratio of the tubular dilator is provided ina range from 10-15.
 21. The device of claim 15, wherein the tubulardilator has a durometer of between 50-85 Shore D.
 22. The device ofclaim 15, wherein the tubular dilator has a distal end that is disposedover the knot and a proximal end opposite of the distal end, and theproximal end has a diameter that is smaller than a diameter of thedistal end such that the tubular dilator is tapered to converge to theproximal end.
 23. The device of claim 15, wherein the tubular dilatorhas a distal end that is disposed over the knot and a proximal endopposite of the distal end, and the tubular dilator has a flexibilitycharacterized in that the dilator bends through at least 180 degreessuch that the proximal end is displaced to contact the distal end. 24.The device of claim 23, wherein the tubular dilator has a flexibilitycharacterized in that the dilator bends through an arc associated with acircle having a radius of about 1 mm.
 25. The device of claim 15,wherein the tubular dilator is fabricated from a solvent-swellableplastic that is shrinkable to provide permanent attachment of thedilator over the knot and to the arm.
 26. The device of claim 15,wherein the arm has a first end connected to both the edge and a portionof the first lateral side of the body portion.
 27. The device of claim15, further comprising: a tab connected to the body portion opposite ofthe edge of the body portion and separated from the arm.
 28. The deviceof claim 15, wherein the tubular dilator is permanently shrunk in placeto the knot.